Society is increasingly becoming concerned with testing of bodily fluids for a number of purposes, such as testing urine samples for drug use, for health indicators, and the like. It is normally a tedious process to aliquot urine samples manually, and it has long been the goal of laboratories, particularly drug testing laboratories, to improve productivity and decrease costs in the handling of urine samples. It is also very important to be able to handle the urine samples without mistake, and to be able to determine whether a urine sample has been tampered with. Therefore some sort of tamper indicating label is provided on the specimen container, the label performing the tamper indicating function as well as providing indicia, such as machine readable indicia like bar coding, to allow effective tracking of the urine specimen.
Robotic elements can be used to automate tedious manual procedures, however when dealing with specimen containers, it is often difficult for the robotic elements to properly handle the containers especially since the tamper indicating and tracking-facilitating labels may interfere with the robotic elements. This may cause interruptions in processing, and potentially damage to the specimen containers or the integrity of the system, therefore heretofore it has been difficult to effectively automate aliquoting of urine samples utilizing robotic elements.
According to the present invention, a specimen container label, a specimen container, and a method of handling a specimen container, are provided which allow automation of laboratory handling of specimens, including improving the productivity and decreasing the costs of aliquoting urine samples, particularly for drug testing laboratories. The labeling system and procedure according to the present invention allows for effective engagement of the urine specimens with a robotic element while still effectively performing the functions of tamper indication and tracking. The particularly designed label according to the present invention is used with other conventional labels, such as main sample labels, sample B labels, and box/bag seal labels, for effective tracking, labeling, etc., of urine specimens, and may increase the productivity of aliquoting urine samples from about 30 per hour (when done manually) to about 300 per hour (when done automatically using robotic elements).
The labeling system according to the present invention is easy to use at collection sites, that is the labeling system can be used by relatively poorly trained or untrained personnel. The system according to the invention does not differ too significantly from present procedures, which makes its implementation far more practical and expeditious. The labeling system is particularly compatible with the SPS Robotics System, and keeps the robotic arm free of adhesive, and minimizes the label waste. The system according to the invention also provides maximum flexibility with respect to numbering and bar coding, and may be printed on press, or on site by the customer. The label material utilized according to the invention can securely adhere to the specimen container within a minute, has lightweight face stock and an aggressive adhesive to maximize tamper evidency, and will maintain adhesion even if the samples get wet. The label maintains its tamper evident functions even in a wide range of temperatures, e.g. from -40-180.degree. F., and has a long life (typically over five years). The label may also be used with various security features such as serrated edges, interlocking security circles, hash cuts, and the like.
According to one aspect of the present invention a specimen container label is provided comprising the following components: A label substrate having a top surface and a bottom surface. Pressure sensitive adhesive provided over a sufficient area of the bottom surface to effectively secure the label substrate to a specimen container. The substrate including a central enlarged portion, with at least one wing extending outwardly from the central enlarged portion. And, an opening in the substrate at the central portion which allows a robotic element to handle a specimen container cover over which the substrate central portion is applied.
The specimen container label according to the invention also preferably has the following additional features: The at least one wing comprises at least two wings. The central enlarged portion is substantially circular in plan, and the opening is also substantially circular in plan. The label further comprises indicia, including machine readable indicia (e.g. bar coding), on the label substrate top surface. The label further comprises a release liner having substantially the same shape and dimensions as the label substrate, and covering the pressure sensitive adhesive, and readily removable from the pressure sensitive adhesive to expose the adhesive. The label further comprises a patch engaging the bottom surface of the label substrate and closing the opening in the substrate, the patch of material (e.g. glassine) that may be much more readily punctured by robotic element than the label substrate. And, the label may further comprise machine readable indicia on the top surface; and the label substrate is releasably mounted on a business form containing at least one other label having the same machine readable indicia thereon.
According to another aspect of the present invention a specimen container is provided comprising the following components: A body having an open top. A cover for the body open top, including a portion thereof for handling by a robotic element. And, a label holding the cover on the body in a predetermined position so that breaking of the label indicates that the cover may have been opened, the label comprising a central enlarged portion engaging the cover, with at least one wing extending outwardly from the central enlarged portion and engaging the body; and an opening in the label at the central portion which allows a robotic element to handle the cover, the central portion and the at least one wing at least in part held to the cover and body by pressure sensitive adhesive.
The specimen container body, cap, and label may have further particulars as follows: The body comprises a vial and the cover comprises a screw on cap having a top surface having a substantially circular peripheral portion, an annular opening adjacent the peripheral portion, and a central substantially cylindrical portion, the opening in the label central enlarged portion overlying the cap central substantially cylindrical portion. The label central enlarged portion is substantially circular in plan, having substantially the same diameter as the vial cap. The label has visible machine readable indicia on at least one of the central portion and the wing. The at least one wing comprises at least two wings engaging the body on substantially opposite sides of the central portion. And, the label may further comprise a patch engaging the bottom surface of the label and closing the opening in the substrate, the patch of material that may be much more readily punctured by robotic element than the label substrate.
According to another aspect of the present invention a method of handling a specimen container comprising a body with an open top covered by a cover, the body having a specimen therein, using a label having an enlarged central portion and at least one wing with top and bottom faces and pressure sensitive adhesive on the bottom face of each, and an opening in the central portion, is provided. The method comprises: (a) Placing the central portion of the label on the specimen container cover, and the at least one wing on the specimen container body, so that the pressure sensitive adhesive holds the cover to the body in a manner that will indicate tampering. (b) Shipping the specimen container to a laboratory without disturbing the label in a way that indicates tampering. (c) Engaging the cover with a robotic element by moving the robotic element through the opening in the label into contact with the cover. And, (d) aliquoting the specimen container using the robotic element.
The method acts may be further practiced as indicated by the following: Where the specimen container comprises a vial, and the cover for the specimen container comprises a screw threaded cap for covering the vial, then (d) is practiced in part by twisting the screw on cap with the robotic element to unscrew the cap, and break the seal provided by the label. Where the opening in the label is covered by a glassine patch, and then (c) is practiced by the robotic element piercing the glassine patch to engage the cap. Where the cap for the vial has a peripheral ring, an annular space adjacent the peripheral ring, and a central substantially cylindrical upstanding portion, then (c) is practiced to move the robotic element through the opening to grasp the substantially cylindrical upstanding portion.
It is the primary object of the present invention to provide a simple yet effective specimen container label system that facilitates automation of specimen container handling, will not adversely impact labeling at the collection site, and will not interfere with other intended functions of the labeling system. This and other objects of the invention will become clear from an inspection of the detailed description of the invention and from the appended claims.